Dosage guidance:
Safety: Dosing varies depending upon the product and indication; use caution. Administer in a health care setting that includes cardiopulmonary monitoring and can provide resuscitation if necessary.
Blood flow, tissue perfusion, and vessel visualization: Infants ≥1 month, Children, and Adolescents: IC-Green, Spy Agent Green: IV: 1.25 to 5 mg; lower doses may be used for younger patients and/or patients with lower body weight. Additional doses may be administered as needed to obtain imaging sequences during the procedure; not to exceed a maximum total dose: 2 mg/kg.
Extrahepatic biliary ducts imaging: Children ≥12 years and Adolescents: IC-Green, Spy Agent Green: IV: 2.5 mg at least 45 minutes prior to surgery; additional doses may be administered as needed to obtain imaging during the procedure; not to exceed a maximum total dose: 2 mg/kg.
Ophthalmic angiography: Infants, Children, and Adolescents: IC-Green: IV: Dose is variable based on patient age/weight, imaging equipment, and technique used; administer once, not to exceed a maximum of 40 mg/dose (Ref).
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
(For additional information see "Indocyanine green: Drug information")
US labeling:
Blood flow, tissue perfusion, and vessel visualization (Spy Agent Green) : IV: 1.25 to 5 mg for a single image sequence or 3.75 to 10 mg for visualization of extremities through the skin; additional doses may be administered at the discretion of the imaging health care provider. Maximum total dose: 2 mg/kg. Immediately follow with a 10 mL bolus of NS.
Cardiac output determination (IC Green): IV: 5 mg injected rapidly via a cardiac catheter; maximum total dose: 2 mg/kg.
Note: An average of 5 dilution curves are needed in a diagnostic cardiac catheterization; doses are usually injected in 1 mL volume. Flush dye from catheter with NS to prevent hemolysis.
Extrahepatic biliary ducts imaging (Spy Agent Green): IV: 2.5 mg as a single dose at least 45 minutes prior to surgery; additional doses may be administered to obtain imaging sequences. Maximum total dose: 2 mg/kg.
Hepatic function studies (IC Green): IV: 0.5 mg/kg; patient should be in a fasting basal state.
Lymphatic mapping of breast cancer (Spy Agent Green): Intradermal: 0.25 mg per breast (divided as 2 injections of 0.05 mL of a 2.5 mg/mL solution); an additional 0.375 mg (divided as 3 injections of 0.05 mL) is recommended if lymphatic flow towards the axillary lymph nodes is not visualized.
Lymphatic mapping of cervical and uterine cancer (Spy Agent Green): Interstitial: 5 mg (divided as 4 injections of 1 mL of a 1.25 mg/mL solution) into cervix.
Ophthalmic angiography (IC Green): IV: Up to 40 mg (depending on the imaging equipment and technique used); immediately follow with a 5 mL bolus of NS.
Canadian labeling:
Blood flow and tissue perfusion imaging: IV: 1.25 mg to 5 mg for a single image sequence or 3.75 mg to 10 mg for visualization of extremities through the skin; an additional 2 to 3 doses may be administered at the discretion of the imaging health care provider. Maximum total dose: <2 mg/kg. Immediately follow with a 10 mL bolus of NS.
Extrahepatic biliary anatomy imaging: IV: 2.5 mg; an additional 2 to 3 doses may be administered at the discretion of the imaging health care provider. Maximum total dose: <2 mg/kg.
Lymph node and lymphatic vessels imaging: Interstitial: 5 mg (divided as 4 injections of 1.25 mg/mL) into cervix.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adults.
1% to 10%: Dermatologic: Skin discoloration (1%; including skin discoloration at injection site)
Postmarketing:
Cardiovascular: Hemodynamic deterioration (decreased blood pressure, increased heart rate) (Zhai 2017)
Dermatologic: Urticaria (Higuchi 2019)
Hypersensitivity: Anaphylactic shock (Higuchi 2019), anaphylaxis (Higuchi 2019), type I hypersensitivity reaction (Meira 2020)
History of hypersensitivity (anaphylaxis) to indocyanine green or any component of the formulation (Spy Agent Green); hypersensitivity to iodides (IC Green).
Concerns related to adverse effects:
• Anaphylaxis: Anaphylaxis and urticaria has been reported, including anaphylactic deaths during IV administration, have been reported; cardiopulmonary resuscitation personnel and equipment should be readily available.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Solution Reconstituted, Injection:
Spy Agent Green: Methyl salicylate 10% and menthol 3% (1 ea)
SPY-PHI Kit: Methyl salicylate 10% and menthol 3% (1 ea)
Solution Reconstituted, Injection [preservative free]:
IC Green: Methyl salicylate 10% and menthol 3% (1 ea)
Spy- MIS Kit: Methyl salicylate 10% and menthol 3% (1 ea)
Solution Reconstituted, Intravenous:
IC Green: 25 mg (1 ea [DSC])
Generic: 25 mg (1 ea)
Yes
Solution (reconstituted) (IC Green Injection)
25 mg (per each): $357.29
Solution (reconstituted) (Indocyanine Green Intravenous)
25 mg (per each): $254.69
Solution (reconstituted) (Spy Agent Green Injection)
25 mg (per each): $5,459.05
Solution (reconstituted) (Spy- MIS Kit Injection)
25 mg (per each): $1,669.50
Solution (reconstituted) (SPY-PHI Kit Injection)
25 mg (per each): $883.34
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Reconstituted, Injection:
Spy Agent Green: Methyl salicylate 10% and menthol 3% (1 ea)
Spy Agent Green AIM/Pinpoint: Methyl salicylate 10% and menthol 3% (1 ea)
Spy Agent Green Lymphat Pinpoi: Methyl salicylate 10% and menthol 3% (1 ea)
Spy Agent Green Spy Elite: Methyl salicylate 10% and menthol 3% (1 ea)
Spy Agent Green Spy Phi: Methyl salicylate 10% and menthol 3% (1 ea)
Solution Reconstituted, Intravenous:
Generic: 25 mg (1 ea)
Parenteral: IV:
Blood flow, tissue perfusion, and vessel visualization: IC-Green, Spy Agent Green: Infants, Children, and Adolescents: Administer via central or peripheral vein by rapid bolus; follow immediately with NS flush (eg, 10 mL in adults). Note: The use of 2 syringes (one with indocyanine green and the other with NS flush) connected to three-way stopcock is recommended.
Extrahepatic biliary ducts imaging: IC-Green, Spy Agent Green: Children ≥12 years and Adolescents: Inject dose at least 45 minutes prior to surgery.
Ophthalmic angiography: IC-Green: Infants, Children, and Adolescents: Administer by IV injection; may use peripheral site (antecubital vein may be used); follow dose immediately with 5 mL NS flush.
US labeling:
IV:
Blood flow, tissue perfusion, and vessel visualization: Administer as a bolus injection via a central or peripheral IV line using a 3-way stopcock; immediately follow with a 10 mL bolus of NS. Use with the SPY Elite or PINPOINT Fluorescence imaging systems or an FDA-approved imaging device that is specifically indicated for use with indocyanine green for fluorescence imaging of blood flow, tissue perfusion, and vessels. A visible fluorescence response in blood vessels may be seen within 5 to 15 seconds after administration.
Cardiac output determination: In the performance of dye dilution curves, administer as a single bolus as rapidly as possible via a cardiac catheter into selected sites in the vascular system. Inject the dose of dye in 1 mL volume; an average of 5 dilution curves are recommended in the procedure. Attach a recording instrument (oximeter or densitometer) to a needle or catheter for sampling of the dye-blood mixture from a systemic arterial sampling site. Use sterile water for injection to rinse the syringe; use isotonic saline to flush the residual dye from the cardiac catheter into circulation to avoid hemolysis; saline should be used in all other parts of the catheterization procedure. See manufacturer's labeling for specific information regarding calibration of dye curves.
Extrahepatic biliary ducts: Administer at least 45 minutes prior to surgery. Use with the PINPOINT Fluorescence imaging system or an FDA-approved imaging device that is specifically indicated for use with indocyanine green for fluorescence imaging of extrahepatic biliary ducts. A visible fluorescence response in blood vessels may be seen within 45 minutes after administration.
Hepatic function studies: Inject into the lumen of an arm vein as rapidly as possible, without allowing the dye to escape outside the vein. If the photometric method is used, prior to injecting indocyanine green, withdraw 6 mL venous blood from the patients arm for serum blank and standard curve construction, and through the same needle, inject the correct amount of dye. Ear oximetry has also been used; see manufacturer's labeling for additional information.
Ophthalmic angiography studies: Administer as a bolus injection into the antecubital vein; immediately follow with a 5 mL bolus of normal saline.
Intradermal: Lymphatic mapping of breast cancer: Administer into the peri-areolar area at the 12 and 9 o'clock positions for the right breast or at the 12 and 3 o'clock positions for the left breast; if an additional dose is necessary, administer at the 12, 3, and 9 o'clock positions. Use with the SPY Portable Handheld Imaging (SPY-PHI) system or an FDA-approved imaging device that is specifically indicated for use with indocyanine green for fluorescence imaging of lymph nodes and delineation of lymphatic vessels during lymphatic mapping of breast cancer. A visible fluorescence response in lymph nodes and lymphatic vessels may be seen within 1 minute after administration.
Interstitial: Lymphatic mapping of cervical and uterine cancer: Administer into the cervix at the 3 and 9 o'clock positions with a superficial (1 to 3 mm) and deep (1 to 3 cm) injection at each position for a total of 4 injections. Use with the PINPOINT Fluorescence imaging system or an FDA-approved imaging device that is specifically indicated for use with indocyanine green for fluorescence imaging of lymph nodes and delineation of lymphatic vessels during lymphatic mapping of cervical and uterine cancer. A visible fluorescence response in lymph nodes and lymphatic vessels may be seen within 1 minute after administration.
Canadian labeling:
IV:
Blood flow and tissue perfusion imaging: Administer as a bolus injection via a central or peripheral IV line using a three-way stopcock; immediately follow with a 10 mL bolus of NS. A visible fluorescence response in blood vessels may be seen within 5 to 15 seconds after administration.
Extrahepatic biliary anatomy imaging: Administer ~45 minutes prior to surgery; a visible fluorescence response in blood vessels may be seen ~45 minutes after administration.
Interstitial: Lymph node and lymphatic vessels imaging: Administer into the cervix at the 3 and 9 o'clock positions with a superficial (1 to 3 mm) and deep (1 to 3 cm) injection at each position for a total of 4 injections while patient is under anesthesia. A visible fluorescence response in lymph nodes and lymphatic vessels may be seen within 1 minute after administration.
Store at 20°C to 25°C (68°F to 77°F). Use within 6 hours of dilution. Discard if precipitate is present.
IV: Ophthalmic angiography (IC-Green: FDA approved in pediatric patients [age not specified] and adults); fluorescence imaging of vessels (micro- and macrovasculature), blood flow, and tissue perfusion before, during, and after GI, organ transplant, plastic, micro- and reconstructive, and vascular surgeries (including minimally invasive surgical procedures) (IC-Green, Spy Agent Green: FDA approved in ages ≥1 month and adults); fluorescence imaging of extrahepatic biliary ducts (IC-Green, Spy Agent Green: FDA approved in ages ≥12 years and adults).
Interstitial injection: Fluorescence imaging of lymph nodes and delineation of lymphatic vessels during lymphatic mapping in patients with cervical and uterine cancer for which this procedure is a component of intraoperative management (IC-Green, Spy Agent Green: FDA approved in adults).
Intradermal: Fluorescence imaging of lymph nodes and delineation of lymphatic vessels during lymphatic mapping in patients with breast cancer for which this procedure is a component of intraoperative management (Spy Agent Green: FDA approved in adults).
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program
There are no known significant interactions.
Reproduction studies have not been done.
Symptoms of anaphylaxis and hypersensitivity reaction during infusion.
Normal percentage disappearance rate is 18% to 24% per minute.
Indocyanine dye is a tricarbocyanine dye that permits recording of the indicator-dilution curves for both diagnostic and research purposes independently of fluctuations in oxygen saturation.
Protein binding: 95% to 98% to albumin.
Half-life elimination: 2.5 to 3 minutes.
Excretion: Bile.